Patient Reported Outcome Measurements (PROMs) Impact on Clinical Outcome in firsT Line settIng Non- Small-Cell Lung Cancer (NSCLC) According to Chemo- Immunotherapy reGimen

NCT07061379 | Recruiting FDA Drug

• 1 other identifier: PROMOTING
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, national pharmacological observational study that has as its overall goal to implement a set of validated and agreed upon European-wide questionnaires (PROMs - patient's reported outcomes) to assess patients' perceptions of aspects of their lives based on the treatment they are receiving. Specifically, with the research we present here, we aim to obtain data on patients' health and condition, including quality of life, symptom status, physical function, mental health (anxiety and depression), sleep quality, and sexuality as useful indicators not only of patient well-being but also of the effectiveness of the treatment itself. The study involves the following: patients will be asked to complete online questionnaires at the following timepoints: before the start of treatment, after 4 and 8 treatment cycles, and at disease progression. Data will also be collected regarding the patient's oncological medical history, treatment performed, response to treatment at CT/PET reevaluations, any toxicities that arose during treatment.

Conditions

PROMs

Keywords

NSCLC; immunotherapy

Outcome Measures

Primary Outcomes (1)

• To evaluate what kind of first line treatment for metastatic lung adenocarcinoma has a better impact on quality of life of the patients

  QoL domains assessed by EORTC QLQ-C-30 and LC13 at baseline and after 4 cycles. All questionnaires used in this study are validated questionnaires

  Baseline, after 4 cycles

Secondary Outcomes (1)

• To assess the impact on overall survival of all the PROMs items under investigation

  After 4 cycles, after 8 cycles, and at disease progression

Other Outcomes (2)

• - To assess the impact on overall survival of all the PROMs items under investigation in squamous NSCLC

  After 4 cycles, after 8 cycles and at disease progression

• - To assess the impact on PFS and RR in patients receiving different first line regimens

  Baseline, after 4 cycles, after 8 cycles and at disease progression

Study Arms (2)

Cohort A: patient treated with chemo-ICI regimen as first line therapy

Cohort A: Carboplatin/Cisplatin+Pemetrexed+Pembrolizumab/Cemiplimab (Keynote 189, EmpowerLung 3) for 4 cycles and then maintenance with Pemetrexed+Pembrolizumab/Cemiplimab up to 2 years or disease progression or unacceptable toxicity

Drug: Carboplatin/Cisplatin+Pemetrexed+Pembrolizumab/Cemiplimab for 4 cycles and then maintenance with Pemetrexed+Pembrolizumab/Cemiplimab up to 2 years or disease progression or unacceptable toxicity

Cohort B: patient treated with double ICI-chemo regimen as first line therapy

Cohort B: Carboplatin/Cisplatin+Pemetrexed+Nivolumab+Ipilimumab (CheckMate9LA) for 2 cycles and then maintenance with Nivolumab q21 and Ipilimumab q42 up to 2 years or disease progression or unacceptable toxicity

Drug: Carboplatin/Cisplatin+Pemetrexed+Nivolumab+Ipilimumab for 2 cycles and then maintenance with Nivolumab q21 and Ipilimumab q42 up to 2 years or disease progression or unacceptable toxicity

Interventions

Carboplatin/Cisplatin+Pemetrexed+Pembrolizumab/Cemiplimab for 4 cycles and then maintenance with Pemetrexed+Pembrolizumab/Cemiplimab up to 2 years or disease progression or unacceptable toxicity DRUG

Cohort A: Carboplatin/Cisplatin+Pemetrexed+Pembrolizumab/Cemiplimab (Keynote 189, EmpowerLung 3) for 4 cycles and then maintenance with Pemetrexed+Pembrolizumab/Cemiplimab up to 2 years or disease progression or unacceptable toxicity

Cohort A: patient treated with chemo-ICI regimen as first line therapy

Carboplatin/Cisplatin+Pemetrexed+Nivolumab+Ipilimumab for 2 cycles and then maintenance with Nivolumab q21 and Ipilimumab q42 up to 2 years or disease progression or unacceptable toxicity DRUG

Cohort B: Carboplatin/Cisplatin+Pemetrexed+Nivolumab+Ipilimumab (CheckMate9LA) for 2 cycles and then maintenance with Nivolumab q21 and Ipilimumab q42 up to 2 years or disease progression or unacceptable toxicity

Cohort B: patient treated with double ICI-chemo regimen as first line therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of unresectable or advanced NSCLC eligible for first line chemo- ICI (Cohort A) or double ICI-chemo (Cohort B) regimens. Up to 50 patients with squamous histology, treated with any chemo- immunotherapy scheme will be monitored for QoL parameters as a prospective exploratory observational cohort and will not be included in the sample size calculation.

You may qualify if:

• Age \> 18 years
• Diagnosis of Stage IV NSCLC with PD-L1 \<50%, without actionable genomic alterations
• Signed Informed Consent Form (ICF) to the study
• Patients eligible to receive first line treatment with combo chemo-immuno treatments as standard of care

You may not qualify if:

• \- Patients unable to fill the questionnaires due to neurological comorbidities

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• AOU Città della Salute e della Scienza di Torino - Presidio Molinette: collaborator
• Fondazione Policlinico Campus Bio-Medico: collaborator
• ASST Lariana, Como: collaborator
• IRCCS Istituto Nazionale dei Tumori: collaborator
• ASST Grande Ospedale Metropolitano Niguarda: collaborator
• IRCCS San Gerardo dei Tintori, Monza: collaborator
• ASST Spedali Civili di Brescia: collaborator
• Policlinico San Matteo Pavia: collaborator
• Humanitas Research Hospital IRCCS, Rozzano-Milan: collaborator
• Ospedale Vincenzo Monaldi: collaborator

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Italy, 20132, Italy

RECRUITING

MeSH Terms

Interventions

Carboplatin; cemiplimab

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

Sara Oresti, Medical Oncologist

CONTACT

+39 022643 8195; oresti.sara@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 11, 2025
• Study Start: July 24, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2031
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

IT (1)